English Polski
Vol 2, No 1 (2009)
Research paper
Published online: 2009-02-12

open access

Page views 1052
Article views/downloads 1871
Get Citation

Connect on Social Media

Connect on Social Media

HCV RNA and HIV RNA detection by Procleix HIV-1/HCV Assay in blood donors with various results of anti-HCV and anti-HIV EIA

Piotr Grabarczyk, Joanna Medyńska, Grzegorz Liszewski, Dorota Kubicka-Russel, Ewa Sulkowska, Maria Mikulska, Magdalena Łętowska, Ewa Brojer
Journal of Transfusion Medicine 2009;2(1):26-33.


Background: The aim of the study was to investigate the sensitivity of Procleix HIV1/HCV Assay for HIV RNA and HCV RNA detection, and to analyse the frequency of viral nucleic acid detection in blood donors with various EIA test results.
Material and methods: The 95% sensitivity of the Procleix test was 6.2 IU HCV RNA /ml and 44.5 IU HIV RNA /ml. HCV RNA was detected in 71/392 (18.1%) anti-HCV positive and HIV RNA in 21/557 (3.8%) EIA HIV-reactive donors. The frequency of HCV RNA detection correlated with signal/cut-off ratios (S/C ratio) of EIA. HCV RNA was found in 68/105 (64.8%) of the donors if it was >4, in 1/85 (1.2%) if it was between 2.00 and 3.99, and in 2 out of 202 donors (1%) if it was between 1.00 and 1.99. HIV RNA was detected in all 21 blood donors positive in EIA and Western Blot.
Results and conclusions: The study demonstrated that Procleix HIV1/HCV Assay is very sensitive and can be used in the reference laboratory to confirm active infection in donors with positive results. We observed a low frequency of active infection in Polish blood donors with repeated reactive results in HCV and HIV EIA. The high S/C ratio value (> 4) of EIA is a good predictor of HCV RNA detection, but HCV RNA can also be detected in single donors with low ratio values of the EIA test.

Article available in PDF format

View PDF (Polish) Download PDF file


  1. Głoskowska-Moraczewska Z, Kacperska E, Seyfried H. Assessment of anti-HCV screening and supplemental assays. Acta Haematologica Polonica. 1993; 44: 273–280.
  2. Moraczewska Z, Mikulska M, Brojer E, et al. RNA HCV detection in Polish blood donors and in plasma derivatives. Acta Haematologica Polonica. 2000; 31(4): 391–397.
  3. Brojer E. Blood screening by nucleic acid tests – current issues and perspectives. Acta Haematologica Polonica. 2003; 34(supl. 1): 28–32.
  4. Gentili G, Pisani G, Bisso G, et al. EQA Participants. Hepatitis C virus testing of plasma pools by nucleic acid amplification technology: external quality assessment. Vox Sang. 2001; 81(3): 143–147.
  5. Yang Y, Lamendola MH, Mendoza M, et al. Performance characteristics of the COBAS AmpliScreen HIV-1 test, version 1.5, an assay designed for screening plasma mini-pools. Transfusion. 2001; 41(5): 643–651.
  6. CPMP The introduction of nucleic acid amplification technology (NAT) for the detection of hepatitis C virus RNA in plasma pools. CPMP/BWP/390/97 1998.
  7. Simmonds P. Viral heterogeneity of the hepatitis C virus. Journal of Hepatology. 1999; 31: 54–60.
  8. Brojer E, Gronowska A, Medynska J, et al. The hepatitis C virus genotype and subtype frequency in hepatitis C virus RNA-positive, hepatitis C virus antibody-negative blood donors identified in the nucleic acid test screening program in Poland. Transfusion. 2004; 44(12): 1706–1710.
  9. Raghuraman S, Subramaniam T, Daniel D, et al. Occurrence of false positives during testing for antibodies to hepatitis C virus among volunteer blood donors in India. J Clin Microbiol. 2003; 41(4): 1788–1790.
  10. Seed CR, Margaritis AR, Bolton WV, et al. Virology Subcommittee of the National Donor and Product Safety Committee, Australian Red Cross Blood Service. Improved efficiency of national HIV, HCV, and HTLV antibody testing algorithms based on sequential screening immunoassays. Transfusion. 2003; 43(2): 226–234.
  11. Alter MJ, Kruszon-Moran D, Nainan OV, et al. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med. 1999; 341(8): 556–562.
  12. Dufour DR, Talastas M, Fernandez MDA, et al. Low-positive anti-hepatitis C virus enzyme immunoassay results: an important predictor of low likelihood of hepatitis C infection. Clin Chem. 2003; 49(3): 479–486.
  13. Hyland C, Seed CR, Kiely P, et al. Follow-up of six blood donors highlights the complementary role and limitations of hepatitis C virus antibody and nucleic acid amplification tests. Vox Sang. 2003; 85(1): 1–8.
  14. Caudai C, Padula MG, Bastianoni I, et al. Antibody testing and RT-PCR results in hepatitis C virus (HCV) infection: HCV-RNA detection in PBMC of plasma viremia-negative HCV-seropositive persons. Infection. 1998; 26(3): 151–154.
  15. Rodger AJ, Roberts S, Lanigan A, et al. Assessment of long-term outcomes of community-acquired hepatitis C infection in a cohort with sera stored from 1971 to 1975. Hepatology. 2000; 32(3): 582–587.
  16. Seeff LB, Hollinger FB, Alter HJ, et al. Long-term mortality and morbidity of transfusion-associated non-A, non-B, and type C hepatitis: A National Heart, Lung, and Blood Institute collaborative study. Hepatology. 2001; 33(2): 455–463.
  17. Ownby HE, Korelitz JJ, Busch MP, et al. Loss of volunteer blood donors because of unconfirmed enzyme immunoassay screening results. Retrovirus Epidemiology Donor Study. Transfusion. 1997; 37(2): 199–205.
  18. Sharma UK, Stramer SL, Wright DJ, et al. Retrovirus Epidemiology Donor Study. Impact of changes in viral marker screening assays. Transfusion. 2003; 43(2): 202–214.
  19. Georgoulias VA, Malliaraki NE, Theodoropoulou M, et al. Indeterminate human immunodeficiency virus type 1 western blot may indicate an abortive infection in some low-risk blood donors. Transfusion. 1997; 37(1): 65–72.
  20. Allain JP, Kitchen A, Aloysius S, et al. Safety and efficacy of hepatitis C virus antibody screening of blood donors with two sequential screening assays. Transfusion. 1996; 36(5): 401–405.